https://medicaldevicecourses.com/members/gingeranderson/activity/ Activity feed for gingeranderson. Fri, 24 Apr 2026 17:08:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 902844e7736cce577abbd19dc820cecc https://medicaldevicecourses.com/activity/p/14386/ Wed, 15 May 2019 18:55:40 -0400 I feel that this isn’t too strict. Even though it might start as someone just paying for dinner, it could lead to other gifts or people even expecting gifts simply because they did business with someone. I have had doctors…   Read more»

]]> 20adad9cfa7c59fa85f3edae16844478 https://medicaldevicecourses.com/activity/p/14385/ Wed, 15 May 2019 18:55:39 -0400 I enjoyed taking this class. I feel like you are one of the only professors that prepares students for the real world. Even though NIH strongly encourages institutions to provide career services and help students plan for the future (usually…   Read more»

]]> 8ddccf73741ae82a58f4a0e02faeed32 https://medicaldevicecourses.com/activity/p/14384/ Wed, 15 May 2019 18:55:39 -0400 Eli Lilly Co was involved in giving kickbacks to doctors for many years involving diabetes and osteoporosis drugs. They gave free nursing services to those doctors. The nurses were supposed to health the patients manage their disease but instead strong…   Read more»

]]> dbdb6fa17fd571729f24b52e626d1997 https://medicaldevicecourses.com/activity/p/14239/ Wed, 15 May 2019 18:54:20 -0400 I would ideally want to work with people who I like as well as people who are experts. When I worked at General Dynamics Electric Boat, I collaborated with people who worked at the Naval Research Laboratory, Lockheed Martin, small…   Read more»

]]> fab402d9f1ec00711871391f8da861ed https://medicaldevicecourses.com/activity/p/14238/ Wed, 15 May 2019 18:54:20 -0400 I think the best way to get rid of the negative competition is to develop a rapport within the company between employees. This is done through company events. At a nuclear plant I use to work at, every year they…   Read more»

]]> 4630accfd1e1d3fe0f23f4f40889fab6 https://medicaldevicecourses.com/activity/p/14237/ Wed, 15 May 2019 18:54:19 -0400 When I worked at General Dynamics Electric Boat, I feel it was more of a functional organization. The functional heads have a lot of power. I had a great rapport with my functional manager so I didn’t mind it but…   Read more»

]]> 9992efbc2394cdabed140908d8e3f752 https://medicaldevicecourses.com/activity/p/14102/ Wed, 15 May 2019 18:51:55 -0400 To run a risk management meeting, first I would identify the technical experts that are related to that topic. Then I would get everyone in a room and I would have a brain storming session. I would first start by…   Read more»

]]> ca6ae88ffbb4cf03fb9c72ce1d6e57f2 https://medicaldevicecourses.com/activity/p/14101/ Wed, 15 May 2019 18:51:55 -0400 As a nuclear engineer, risk assessment and management is very important. I wanted to highlight on one of the risk analysis tools used for risk management for nuclear power plants. When I worked at a nuclear power plant, I used…   Read more»

]]> d9844d7563369c87760d0566f149c976 https://medicaldevicecourses.com/activity/p/14100/ Wed, 15 May 2019 18:51:54 -0400 For high severity risk, I would use avoidance. I want to get rid of the high severity risk. The best way to do this is by avoidance because mitigation just lowers the risk of it happening, acceptance is just accepting…   Read more»

]]> bdb7ef6445a50e07a6080c2ccb01f03d https://medicaldevicecourses.com/activity/p/13964/ Wed, 15 May 2019 17:09:56 -0400 To make a successful validation process you need to clearly state your inputs and make sure they match your user’s needs. You must think critically about what each input means so that you can design a test that covers that….   Read more»

]]> feaead47361ba7bbdabab5dc883551c3 https://medicaldevicecourses.com/activity/p/13963/ Wed, 15 May 2019 17:09:55 -0400 I choose a Band-Aid. The verification protocol makes sure the inputs matches the outputs. I believe the inputs would be that it sticks to the skin but can be removed without much force and that it doesn’t irritate the skin….   Read more»

]]> d2d98edfe4c40be2a6b0e81e13fbfd53 https://medicaldevicecourses.com/activity/p/13962/ Wed, 15 May 2019 17:09:55 -0400 Design review meetings are critical for the success of the product. At my old company whenever I held a design review meeting, I would send out all the materials a few weeks before the actual meeting. I would ask the…   Read more»

]]> 7ab4e73298f512e2a6e461012de33375 https://medicaldevicecourses.com/activity/p/13871/ Wed, 15 May 2019 17:08:59 -0400 Above, a lot of people listed all the requirements but I wanted to elaborate on one. I think the FDA looks to see that the design changes were implemented. This might seem trivial but its something to look for because…   Read more»

]]> 4a56e8d7d59691e0d24804ee483ceb53 https://medicaldevicecourses.com/activity/p/13870/ Wed, 15 May 2019 17:08:58 -0400 Without sufficient design controls, a number of things can happen. Entire systems can fail due to the inputs not reflecting the standards of the industry. People can get fired after those entire systems fail. Without complete and accurate design controls…   Read more»

]]> efa344ab35ada49d1c47ab6217ad0715 https://medicaldevicecourses.com/activity/p/13868/ Wed, 15 May 2019 17:08:57 -0400 As Adrian stated above, past projects are a source of design inputs. To expand on this, the Design History File (DHF) of other similar projects would be a source of design inputs. The key to choosing design inputs is to…   Read more»

]]> 496bd640a5a0832c26c3ccdfd128b579 https://medicaldevicecourses.com/activity/p/13692/ Wed, 15 May 2019 17:07:18 -0400 I think the advantage of a clinical trial is being about to actually see the product of years and years worth of research. To get to a clinical trial means that there was a lot of data that got it…   Read more»

]]> 6493b40ed0e4db3b092be0a8425dcaeb https://medicaldevicecourses.com/activity/p/13691/ Wed, 15 May 2019 17:07:17 -0400 I would be a clinical project manager. I am good at looking at the big picture and the main goal of the project but also break that down into small pieces and organize and motivate people. I learned this while…   Read more»

]]> 2a8f8226e3b8fd2963ec28311b39e381 https://medicaldevicecourses.com/activity/p/13690/ Wed, 15 May 2019 17:07:17 -0400 I think they should put more emphasize on just making sure the person can think critically and actually has a background in research. If you read publications such as “Embracing failure: What the Phase III progesterone studies can teach about…   Read more»

]]> a83f7908d1dfa8f87213a931b1c4ad75 https://medicaldevicecourses.com/activity/p/13540/ Wed, 15 May 2019 17:05:53 -0400 I think “participation marketing” can happen without the company even really trying. A lot of times companies go to college campuses for career fairs and “participation” market without them knowing it. They speak to students about their company and medical…   Read more»

]]> cb934138009705be5533703963f7675f https://medicaldevicecourses.com/activity/p/13539/ Wed, 15 May 2019 17:05:53 -0400 GE Healthcare “GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement…   Read…[Read more]

]]> 9f96b32aa43fd097fc5013a4a5b83669 https://medicaldevicecourses.com/activity/p/13537/ Wed, 15 May 2019 17:05:51 -0400 EI affects sales because people want to do business with people they like and trust. People don’t want to do business with someone who they don’t like because you don’t even want to talk to that person again. Also, I…   Read more»

]]> 641181458f87e4c9be2c15b55833865c https://medicaldevicecourses.com/activity/p/13435/ Wed, 15 May 2019 17:04:52 -0400 Widgets, Inc. is an example of an S-Corp. An example of a C-Corp would be Amazon. I think that companies don’t get to really choose whether they are S or C. I think they just are. Ideally, I think all…   Read more»

]]> 0d04725481ea7da598e0d6e8d135bb98 https://medicaldevicecourses.com/activity/p/13434/ Wed, 15 May 2019 17:04:51 -0400 As stated above, the sons would have to start a new business. In my opinion, this would be a good thing. The sons could start a partnership. The sons would probably not have to pay business income tax under a…   Read more»

]]> 05d05805ba1802308c2142e24332ce02 https://medicaldevicecourses.com/activity/p/13433/ Wed, 15 May 2019 17:04:51 -0400 There are a few reasons why the courts would pierce the corporate veil. One example that I wanted to elaborate on was failure to follow corporate formalities. Of the several ways listed that courts would pierce the corporate veil, I…   Read more»

]]> 430f912c8a23987fb03f06dcb40a32ed https://medicaldevicecourses.com/activity/p/13263/ Wed, 15 May 2019 17:03:23 -0400 I always made friends with the QA people because they had such large control over your job/project. I think them having so much power improved their relationship with other departments because if you piss them off, your job/project will probably…   Read more»

]]> d7d11609dc68b1008bbb8c2f4cb5499b https://medicaldevicecourses.com/activity/p/13262/ Wed, 15 May 2019 17:03:23 -0400 When dealing with the quality department, I think one of the main issues I had was how much the result varies due to the person in the quality department you are dealing with. I know this is a problem lots…   Read more»

]]> 7bfbfdeed646c7bd696b4016679c9d80 https://medicaldevicecourses.com/activity/p/13261/ Wed, 15 May 2019 17:03:22 -0400 The most experience I have working with Quality Assurance and Quality Control is when we replaced a non-nuclear valve on the submarine. They perform a cleanliness test on the valve before installing it. It was just a simple test where…   Read more»

]]> 0ef7b29e43821af23d0ff82fb09adc2b https://medicaldevicecourses.com/activity/p/13114/ Wed, 15 May 2019 17:02:03 -0400 As everyone has stated above, e-cigarettes and cigarettes are regulated by the FDA. I do think e-cigarettes are different than cigarettes due to lots of people I have come across using them to quit smoking. This is exactly how the…   Read more»

]]> 4468613b0760b2e0fba6e7e95876f4c8 https://medicaldevicecourses.com/activity/p/13113/ Wed, 15 May 2019 17:02:03 -0400 Band-aids with Neosporin bandages (the band-aids that come with the Neosporin already applied) are a combination product. It’s primary mode is it protects your wound and also helps treat it. This would be under the CDRH because it is first…   Read more»

]]> ec5cf71fa1065c27493ad62366f7df23 https://medicaldevicecourses.com/activity/p/13112/ Wed, 15 May 2019 17:02:03 -0400 I would think this is a combination drug/device. The primary mode of action would be the function of the hip stem so structural support. This would be under the CDRH and be class 3. The regulatory pathway would like the…   Read more»

]]> b83f37577eba95c5de28d18d7324d1c0 https://medicaldevicecourses.com/activity/p/12961/ Wed, 15 May 2019 17:00:45 -0400 I would prefer to create research that helps current generations. I believe that technologies and information builds upon itself so if you help current generations, you are helping future generations as well. For example, if one creates a cure with…   Read more»

]]> 1bc1f460184d64c6c4998ce84660f7a8 https://medicaldevicecourses.com/activity/p/12960/ Wed, 15 May 2019 17:00:45 -0400 While working at General Dynamics Electric Boat, I helped design and develop new technology for submarines. I worked with Lockheed Martin, the Naval Research Laboratory (NRL), vendors and people who report to congress for money. I was the person who…   Read more»

]]> 2f31410124743e69bb54e6b3fa5e9f13 https://medicaldevicecourses.com/activity/p/12959/ Wed, 15 May 2019 17:00:44 -0400 In industry, research is done based on an immediate need for the product. Unless there is a problem that has to be solved, usually the research isn’t pushed in industry. In academia, research is done based on an immediate or…   Read more»

]]> e3f890c3acb40764d0a59c2dfdda0931 https://medicaldevicecourses.com/activity/p/12797/ Wed, 15 May 2019 16:59:14 -0400 While working at General Dynamics Electric Boat, I was given a project to develop a new technology for submarines. While testing in the Monitoring and Controlling phase of the project, we realized that the device didn’t meet certain standards. We…   Read more»

]]> 3db9ba3ac6a0f8c8f4af3d3a5c1ab9d0 https://medicaldevicecourses.com/activity/p/12796/ Wed, 15 May 2019 16:59:13 -0400 I think there are many challenges to doing project management for medical devices vs other projects. One of the main challenges would be that there might not be a medical device to base your work off of. Other projects have…   Read more»

]]> 013ae21bcd9bf3082b10598510b53a37 https://medicaldevicecourses.com/activity/p/12795/ Wed, 15 May 2019 16:59:13 -0400 While working at General Dynamics Electric Boat, I worked on several projects that had different project managers for different portions of the job. There are pros and cons to this approach. The good thing is that people are experts on…   Read more»

]]> 867b899dbee9653accfe7081672dd822 https://medicaldevicecourses.com/activity/p/12663/ Wed, 15 May 2019 16:58:01 -0400 I would argue that working in academia would give someone the opportunity to work on something that is meaningful to them. In academia, one can do research, take sabbatical, teach or write a textbook (and have the credentials to get…   Read more»

]]> 2728503acef2fd84dc8b56f75623667e https://medicaldevicecourses.com/activity/p/12662/ Wed, 15 May 2019 16:58:00 -0400 I haven’t worked as a biomedical engineer but I have worked as a nuclear engineer for 5 years. My advice would be more general. During internships and later when you work, don’t be afraid to be aggressive. I mean that…   Read more»

]]> 41b3c036de72a091b87510014f10aac9 https://medicaldevicecourses.com/activity/p/12660/ Wed, 15 May 2019 16:57:59 -0400 I think the 3 out of 10 ratio for practical classes versus 7 out of 10 for academic classes is perfect. The student will pick up and learn things on the job and just needs a few classes to get…   Read more»

]]> 6a7bd1910a4d346e7e08f8977b3e55ea https://medicaldevicecourses.com/activity/p/12592/ Wed, 15 May 2019 16:57:24 -0400 I think “praise” and “challenging work” are connected. If people are not stimulated they will not be motivated to work on the said project and there will be no praise. I think the take away is that people want to…   Read more»

]]> 98d23d1586df5ee98574b61450b1807e https://medicaldevicecourses.com/activity/p/12591/ Wed, 15 May 2019 16:57:24 -0400 I believe that they are disconnected because its teamwork vs. individual but I believe they are connected in a strange way.‘individual effort’, ‘making the numbers’, and ‘agreeing with the boss’ leads to ‘teamwork’, ‘achieving challenging stretch goals’, and overall ‘candor’….   Read more»

]]> db5b4f14d9a8ba4f77547ccd5e919fe6 https://medicaldevicecourses.com/activity/p/12589/ Wed, 15 May 2019 16:57:23 -0400 I would choose a manager role. There were several engineers at my company who would never want to be in management and prefer moving up the ladder as a more senior engineer. This was due to that fact that managers…   Read more»

]]> 37bb5cc7d80f1e50aff5068b6e623b48 https://medicaldevicecourses.com/activity/p/12469/ Wed, 15 May 2019 16:56:19 -0400 I believe that to determine if you should outsource a clinical trial or not, you should first develop a scope, WBS, Gantt chart, and budget for these tasks. This will give you an idea of how you would run the…   Read more»

]]> 5f9761fe8e11268717d03f90a4d03cc7 https://medicaldevicecourses.com/activity/p/12468/ Wed, 15 May 2019 16:56:19 -0400 Visualizing the end product motivates me. While working at General Dynamics Electric Boat, I helped design new components for the submarine. Sometimes, while working on a document or setting up a meeting between all the stakeholders, you wonder why are…   Read more»

]]> 78a7cb69bfc2de0bc282064cf46a810c https://medicaldevicecourses.com/activity/p/12467/ Wed, 15 May 2019 16:56:18 -0400 I expected “fair pay” and “benefits” to be higher. I thought the main reason why most people worked was to get paid and have benefits to survive. I actually thought that was the main reason for “work” itself. For me…   Read more»

]]> 780b731504b2f0d3137d80e210d7986b https://medicaldevicecourses.com/activity/p/12395/ Wed, 15 May 2019 16:55:36 -0400 While working at General Dynamics Electric Boat in the electrical engineering dept, there was a shortage of software engineers. Whenever someone finds out that there was a software engineer with any kind of experience in electrical engineering, they usually were…   Read more»

]]> 790e8c6bd5ce18f4d6c02576f3336159 https://medicaldevicecourses.com/activity/p/12390/ Wed, 15 May 2019 16:55:33 -0400 As a nuclear engineer, I have experience working at nuclear plants in probabilistic risk assessment. At one particular nuclear plant, they use bayesian updating to calculate the risk of a component failing in the nuclear plant. They basically collect data…   Read more»

]]> f065acc869b8a92f2d2e04c0896fd6a5 https://medicaldevicecourses.com/activity/p/12387/ Wed, 15 May 2019 16:55:32 -0400 While working at General Dynamics Electric Boat, I was tasked with just replacing a component on a system on the submarine. It was just a simple change out of a component that they said was an old, deteriorated component that…   Read more»

]]> 0ae52e9409b06b37a9150d98345376fc https://medicaldevicecourses.com/activity/p/12287/ Wed, 15 May 2019 16:54:32 -0400 As a nuclear engineer who worked on submarines, a part of the job is lowering radiation exposure or risk for the navy (the customer who works on the product). This means understanding the nature of the problem or radiation. You…   Read more»

]]> 5e82f6d5d10db7a4dad613a6dd9eece5 https://medicaldevicecourses.com/activity/p/12286/ Wed, 15 May 2019 16:54:31 -0400 In my experience, one generally starts following the process ideally: Initiating Processes, Planning Processes, Executing Processes, Closing Processing. While trying to follow the process, problems usually occur that may require you to revisit a previous step. For example, during the…   Read more»

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